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. 2019 May;39(3):252-262.
doi: 10.3343/alm.2019.39.3.252.

Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea

Haeil Park  1 , Jae Eun Shin  2 , Dae Woo Lee  2 , Min Jeong Kim  2 , Hae Nam Lee  3
Affiliations

Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea

Haeil Park et al. Ann Lab Med. 2019 May.

Abstract

Background: The risk of ovarian malignancy algorithm (ROMA) is used for assessing ovarian cancer risk in women with a pelvic mass. Its diagnostic accuracy is variable. We investigated whether the clinically acceptable minimal sensitivity of >80.0% could be obtained with the suggested cutoff of 7.4%/25.3% for pre/postmenopausal women and with adjusted cutoffs set to a specificity of ≥75.0% or a sensitivity of 95.0%, in a hospital with a lower ovarian cancer (OC) prevalence than previously reported.

Methods: ROMA scores were calculated from measurements of human epididymis protein 4 and cancer antigen 125 in blood specimens from 443 patients with a pelvic mass. The ROMA-based risk group was compared against biopsy (N=309) or clinical follow-up with imaging (N=134) results. The ROMA sensitivity and specificity for predicting epithelial OC (EOC) and borderline ovarian tumor (BOT) were calculated for the suggested and adjusted cutoff values.

Results: When targeting BOT and EOC, the prevalence was 7.4% and sensitivity and specificity at the suggested cutoff were 63.6% and 90.7%, respectively. Sensitivity was 81.8% at the 4.65%/13.71% cutoff set to a specificity of 75.0%. When targeting only EOC, the prevalence was 4.1% and sensitivity and specificity at the suggested cutoff were 77.8% and 89.4%, respectively. Sensitivity was 88.9% at the 4.78%/14.35% cutoff set to a specificity of 75.0%.

Conclusions: The sensitivity of ROMA was lower than expected when using the suggested cutoff. When using the adjusted cutoff, its sensitivity reached 80.0%.

Keywords: Borderline ovarian tumor; Epithelial ovarian cancer; Prevalence; Risk of Ovarian Malignancy Algorithm; Sensitivity; Specificity.

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Conflict of interest statement

No potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1. Flow chart of patients.
Abbreviations: ROMA, risk of ovarian malignancy algorithm; EOC, epithelial ovarian cancer; BOT, borderline ovarian tumor.
Fig. 2
Fig. 2. Serum concentrations of (A) HE4, (B) CA125, and (C) ROMA for each disease group and menopausal status (N=443). The cutoffs are shown as horizontal lines.
Abbreviations: HE4, human epididymis protein 4; CA125, cancer antigen 125; ROMA, risk of ovarian malignancy algorithm; BOT, borderline ovarian tumor; EOC, epithelial ovarian cancer; Non-EOC, non-epithelial ovarian cancer.
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